Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT06699394
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2024-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075363', 'term': 'Immunoglobulin Light-chain Amyloidosis'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051416', 'term': 'Focal Adhesion Protein-Tyrosine Kinases'}], 'ancestors': [{'id': 'D011505', 'term': 'Protein-Tyrosine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-20', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete hematological response', 'timeFrame': '3 months, 6 months', 'description': 'Complete hematological response using ISA criteria'}], 'secondaryOutcomes': [{'measure': 'Minimal residual disease', 'timeFrame': '3 months, 6 months', 'description': 'Bone marrow minimal residual disease detected by multi-flow cytometry at the sensitivity of at least 10\\^-5.'}, {'measure': 'Stringent dFLC response', 'timeFrame': '3 months, 6 months', 'description': 'dFLC ≤ 10 mg/L'}, {'measure': 'TRAE', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Treatment realted adverse events'}, {'measure': 'MOD-PFS', 'timeFrame': '12 months, 24 months', 'description': 'The time from the beginning of treatment to death, clinical manifestation of end-stage cardiac or renal failure, or hematologic progression, whichever occurs first.'}, {'measure': 'OS', 'timeFrame': '12 months, 24 months', 'description': 'Overall survival'}, {'measure': 'Renal Response', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Renal Response according to ISA criteria'}, {'measure': 'Cardiac Response', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Cardiac Response according to ISA criteria'}, {'measure': 'Hepatic Response', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Hepatic Response according to ISA criteria'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['teclistamab', 'complete hematological response'], 'conditions': ['AL Amyloidosis']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response.\n\nThis is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.', 'detailedDescription': 'The treatment of amyloidosis should focus more on complete hematological response (CHR) and organ response rate. We hypothesize that teclistamab can deeply eliminate cloned plasma cells in AL patients, achieving a high proportion of complete hematological response.\n\nIn clinical practice, if daratumumab, bortezomib, and venetoclax (for patients with t(11;14)）have been used, the outcome is poor. Also, CHR is correlated with better clinical outcomes. In clinical routine practice, we use teclistamab, a more effective treatment to eliminate clonal plasma cells.\n\nTo further explore efficacy and safety, we designed this prospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of systemic AL amyloidosis;\n2. Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response;\n3. Life expectancy greater than 12 weeks;\n4. HGB ≥70g/L;\n5. Blood oxygen saturation \\> 90%;\n6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;\n7. Informed consent explained to, understood by and signed by the patient.\n\nExclusion Criteria:\n\n1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.\n2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;\n3. Severe or persistent infection that cannot be effectively controlled;\n4. Presence of severe autoimmune diseases or immunodeficiency disease;\n5. Patients with active hepatitis B or hepatitis C (\\[HBVDNA+\\] or \\[HCVRNA+\\]);\n6. Patients with HIV infection or syphilis infection;\n7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.'}, 'identificationModule': {'nctId': 'NCT06699394', 'briefTitle': 'Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study', 'orgStudyIdInfo': {'id': '2023PHB319-001-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'description': 'Teclistamab monotherapy', 'interventionNames': ['Drug: Teclistamab (Tec)']}], 'interventions': [{'name': 'Teclistamab (Tec)', 'type': 'DRUG', 'description': 'Teclistamab is administered subcutaneously with higher step-up doses (SUDs). Patients receive teclistamab with SUDs: 0.2 and 0.7 mg/kg and 1.5 mg/kg in Cycle 1 (2-4 days between doses). 3 mg/kg every 4 weeks will be used in subsequent cycles.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Liu, Dr', 'role': 'CONTACT', 'email': 'pkuphliuyang@bjmu.edu.cn', 'phone': '86-13716926210'}], 'facility': 'Peking University Peoples Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liru Wang', 'role': 'CONTACT', 'email': 'wanglirumail@126.com', 'phone': '010-18618238652'}], 'facility': 'Fuxing Hospital affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yang Dr, M.D.', 'role': 'CONTACT', 'email': 'pkuphliuyang@bjmu.edu.cn', 'phone': '+86-10-88326542'}], 'overallOfficials': [{'name': 'Jin Lu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Jin Lu, MD', 'investigatorAffiliation': 'Peking University'}}}}